Wednesday, July 26, 2017

Ques: I have a question regarding FDA Class 1 medical devices which are exempt from GMP. Are Class 1 devices also exempt from the Design history files and the general records needed for design?

Ans: The question can be taken two ways. First, not all US Class I medical devices are exempt from the CGMPs, 21 CFR 820. That's specifically addressed under 820.1 Scope (s)(1) "... of all finished devices intended for human use." Yes, there are some exceptions . Check for your family of device under 21 CFR 8xx, which will state whether your specific device is exempt.

states that "General Controls" under which all Classes if medical devices fall, including the majority of Class1, include the GMPs.

But, see also:

https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/qualitysystemsregulations/ which states in part:

"FDA has determined that certain types of medical devices are exempt from GMP requirements. These devices are exempted by FDA classification regulations published in the Federal Register and codified in 21 CFR 862 to 892. Exemption from the GMP requirements does not exempt manufacturers of finished devices from keeping complaint files (21 CFR 820.198) or from general requirements concerning records (21 CFR 820.180)."